Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis (RM/NEB-03-10)

April 15, 2011 updated by: Erempharma

Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaide® in Patients With Cystic Fibrosis.

Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the respiratory affection which appears early in neonates.

The constant improvement in symptomatic treatments and care strategies allowed CF patients' life expectancy to be increased over the last decades.

Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.

Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is obtained by inhaled administration of tobramycin and is active against in-vitro resistant Pseudomonas aeruginosa.

Study hypotheses :

Regarding literature data and in-vitro studies, the administration of Nebcinal® 150mg/3ml administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus® in children and adult patients with CF.

Primary objective :

To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Behrouz Kassaï
  • Phone Number: 0033 04 27857732

Study Contact Backup

  • Name: Jean-Paul Salin
  • Phone Number: 0033 0140899260

Study Locations

  • France
      • Lyon, France, 69500
        • Recruiting
        • Centre de Ressource et de Compétence Mucoviscidose Pédiatrique Centre de Référence Mucoviscidose
        • Contact:
        • Principal Investigator:
          • Gabriel Bellon, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults and children aged 6 years old and more
  • Male or female
  • Patients with cystic fibrosis (positive sudoral test, Cl > 60 mmol/L)
  • Followed in a CRCM (CF care centre)
  • FEV1 ≥40%
  • Informed consent collected from adults or parents or legal guardians and children.
  • Affiliation to the National Health Insurance program (Sécurité sociale).

Exclusion Criteria:

  • renal insufficiency defined by a creatinine clearance level superior to 2 mg/dl
  • recent pneumothorax, emphysema, punction or recent pleural biopsy, recent haemoptysis superior to 60 ml within 30 days prior to randomization
  • Acute pulmonary exacerbation pathology, according to conference of consensus (2002), evaluated by :
  • Cough increase
  • Sputum increase
  • Decrease in tolerance to effort
  • Loss of weight, lack of appetite
  • Deterioration of respiratory function
  • Medical history of intolerance, toxicity or allergy to tobramycin, hypersensitivity to aminoside

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm A
experimental treatment (Nebcinal/Aeroneb Idehaler pocket) - 6day-wash out period - standard treatment (Tobi/Pari LC Plus)
Drug: Tobramycin
Other: Arm B
standard treatment (Tobi/Pari LC Plus) - 6day-wash out period - experimental treatment (Nebcinal/Aeroneb Idehaler)
Drug: Tobramycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of tobramycin from 0 to 8h after administration
Time Frame: from 0 to 8h after administration
from 0 to 8h after administration

Secondary Outcome Measures

Outcome Measure
Time Frame
sputum of tobramycin concentrations
Time Frame: from 0 to 8 hours after administration
from 0 to 8 hours after administration
Safety of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®;
Time Frame: 15 days
15 days
Time of nebulization of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®
Time Frame: during nebulization
during nebulization
Satisfaction of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®
Time Frame: after administration of the drug, in average 20 minutes
after administration of the drug, in average 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erempharma

Collaborators

Hospices Civils de Lyon
University of Lyon
Clininfo S.A.
Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME)

Investigators

  • Principal Investigator: Gabriel Bellon, Centre de Resources et de competences pour la mucovisidose
  • Principal Investigator: Isabelle Durieu, Pr, Centre de Resources et de competences pour la mucovisidose Hôpital Lyon Sud
  • Study Chair: behrouz Kassai, Dr, University of Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

April 13, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (Estimate)

April 18, 2011

Study Record Updates

Last Update Posted (Estimate)

April 18, 2011

Last Update Submitted That Met QC Criteria

April 15, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM/NEB-03-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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